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Serzone and Liver Failure
New reports of deaths and severe injuries from liver failure
in patients taking the antidepressant Serzone (nefazodone)
require that the U.S. Food and Drug Administration (FDA) act
immediately to protect U.S. patients, Public Citizen said
on October 29, 2003. Public Citizen submitted a supplement
containing new data to its March 2003 petition requesting
the withdrawal of this uniquely dangerous drug from the market.
Canada announced it would remove from the
market the liver-toxic drug due to its association with "hepatic
adverse events such as jaundice, hepatitis and hepatocellular necrosis."
A "Dear Health Care Professional" letter posted on the Health Canada
Web site makes an irrefutable case for removing the drug,
Public Citizen said in its supplement.
Bristol-Myers Squibb manufactures nefazodone and markets
it under the name Serzone. More than 2.8 million prescriptions were filled
for Serzone in the United States in 2002.
In its original petition, Public Citizen cited 21 cases of
liver failure and 11 deaths from 1994, when nefazodone was
first marketed, to the spring of 2002. A new analysis of the
FDA Adverse Event Reports Database found that, just from April
1, 2002, through May 12, 2003, there were 33 additional reports
of liver failure - including nine deaths - for a total of
55 patients with liver failure, including 20 deaths.
"Typically, it is estimated that only about 10 percent
of cases are reported, meaning that potentially hundreds of
people have died from this drug and hundreds more have been
injured," said Dr. Sidney Wolfe, director of Public Citizen's
Health Research Group. "This drug is no more effective
than other antidepressants, but is uniquely and unpredictably
toxic."
The liver toxicity dangers of nefazodone are compounded by
the fact that it inhibits a key enzyme that is involved in the metabolism
of about half of all prescribed drugs, so nefazodone increases
the toxicity dangers of other drugs a patient may be taking. Also, by inhibiting
this enzyme, nefazodone can increase its own concentration with
potentially toxic results.
The FDA in December 2001 notified Bristol-Myers Squibb that
it must add a "Black Box" warning to the package insert for
nefazodone warning of life-threatening liver damage and recommending that physicians
advise their patients to be aware of signs of liver problems. This
strategy has clearly failed to curb the cases of liver failure and death
caused by the drug.
"Once again, the United States is lagging behind other
countries in drug safety. Any delay by the FDA in removing this drug from
the market will cause more patients to be injured or killed," Wolfe
said.
* - Source Public Citizen
Serzone and Liver Failure
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